NCAH PORTAL USER GUIDE #11 v.1

Submitting Labels to Policy, Evaluation and Licensing (PEL)

Issue Date: 3/22/2024 Page 1 of 7 

Where were changes made in the 3/22/2024 version?

1. Page 3, in Entering label-specific information section, a step was added to click “Add Row” to enter labels to 

replace. 

Where were changes made in the 3/27/2020 version?

1. Page 2, in the Attaching Label Documents section, a new option for using a PDF version of the label template

was added and the Word template was updated.

• CVB supplied Word template Label Mounting Sheet - Template A 

• CVB supplied PDF template Label Mounting Sheet - Template C 

Where were changes made in the 5/9/2017 version?

1. Page 2, a footnote was added regarding submission of FDA-EREA labels.

1 Submit FDA-EREA labels as "Incoming Core Documents" attached to a "Correspondence" submission.

2. Page 3, in the Entering label-specific information section, #4 - Distributor:

Distributor: Enter ONLY if the label is a container or a box label. For export labels, the entity responsible 

for distributing the vaccine in the country of destination may be variably identified as the distributor, 

importer, marketer, or equivalent. Consider all of these roles as distributors for this data field. Type any 

part of the Distributor name to display a list of choices in the CVB Distributor list. If the desired Distributor 

is not displayed, select “Not Listed.” Upon receipt of a “Not Listed” submission, the CVB will add the new 

Distributor to the picklist for future use.

Where were changes made in the 3/15/2017 version?

1. Page 2, in the Creating a Label Submission section, a new statement was added to the list:

Tag: Select "Single Tier Labeling" if submitting labeling in full compliance with single-tier rule (APHIS Final 

Rule 2011-0049)

Where were changes made in the 2/22/2017 version?

1. Page 2, in the Creating a Label Submission section, a new statement was added to the list:

Product Code: This must be an assigned code. The labeling functionality for the NCAH Portal will not 

accept the “Unassigned” placeholder for uncoded products. (If you wish to obtain feedback on 

preliminary labeling ideas for a product that has not yet been coded, submit as Correspondence per User 

Guide 10 and do not place on a mounting sheet.)

Where were changes made in the 10/28/2016 version?

1. Page 2, in the Attach Labels section, a new statement was added to the list:

Do not attach more than 5 labels to a single submission. If you need to submit more than 5, please 

contact your reviewer for guidance on the best way to group them.

Where were changes made in the 10/24/2016 version?

1. Page 2, in the Attach Labels section, a clarifying statement was added to the 3rd bullet:

Use the attachment type “Incoming postlicense label” for each actual label submitted for approval.

***Do not use this attachment type for anything other than items submitted on a label mounting 

sheet.***
 NCAH PORTAL USER GUIDE #11 v.1

Submitting Labels to Policy, Evaluation and Licensing (PEL)

Issue Date: 3/22/2024 Page 2 of 7 

1 Submit FDA-EREA labels as "Incoming Core Documents" attached to a "Correspondence" submission.

Creating a label submission

This is a detail guide to be used in conjunction with the 2049 General User Guide. It is not intended for stand-alone use.

This guide pertains to submitting labels that are intended for use on licensed product.

It doesn't matter if the label submission is made before, or after, the product license is granted.

Do NOT use this guide for experimental labels OR labels to be used on unlicensed product exported under the Food 

and Administration’s Export Reform and Enhancement (FDA-EREA) Act of 1996.1

Use the 2049 portal interface to submit labels to Policy, Evaluation, and Licensing, per the instructions in the General User 

Guide. Use the following values:

• Product Code: This must be an assigned code. The labeling functionality for the NCAH Portal will not accept the 

“Unassigned” placeholder for uncoded products. (If you wish to obtain feedback on preliminary labeling ideas for a 

product that has not yet been coded, submit as Correspondence per User Guide 10 and do not place on a mounting 

sheet.)

• Submission type = Labels, postlicense (Remember: this submission type pertains whether labels for use 

on postlicense product are submitted before, or after, a product license is issued)

• Submission subtype = leave blank

• Tag: Select "Single Tier Labeling" ifsubmitting labeling in full compliance with single-tier rule (APHIS Final Rule 

2011-0049)

After saving, attachments can be added. Portal users are given the option to upload an Incoming Post-License Label or

other kind of document.
 NCAH PORTAL USER GUIDE #11 v.1

Submitting Labels to Policy, Evaluation and Licensing (PEL)

Issue Date: 3/22/2024 Page 3 of 7 

• Multiple labels may be attached to one label submission, provided that they are for the same product.

• Each label must be a separate attachment.

• Do not attach more than 5 labels to a single submission. If you need to submit more than 5, please contact your 

reviewer for guidance on the best way to group them.

• Use the attachment type “Incoming postlicense label” for each actual label submitted for approval.

***Do not use this attachment type for anything other than itemssubmitted on a label mounting sheet.***

• Use one of the following CVB supplied templates and the template instructionsfound in User Guide #13 for the 

mounting sheet upon which the label is submitted. Customization of templates is not permitted.

CVB supplied Word template Label Mounting Sheet - Template A

CVB supplied PDF template Label Mounting Sheet - Template C

Attaching label documents
 NCAH PORTAL USER GUIDE #11 v.1

Submitting Labels to Policy, Evaluation and Licensing (PEL)

Issue Date: 3/22/2024 Page 3 of 7 

After electing to add an incoming post-license label,the following information isrequested:

 File: Identify the file to be uploaded.

 Label type: Select from dropdown picklist (e.g., Container, Box)

Tradename: Enter ONLY if the label is a container or a box label. Type any part of the Tradename to display a list of choices in 

the CVB Tradename list. If the desired Tradename is not displayed, select “Not Listed.” Upon receipt of a “Not Listed” 

submission, the CVB will add the new Tradename to the picklist for future use.

Entering label-specific information
 NCAH PORTAL USER GUIDE #11 v.1

Submitting Labels to Policy, Evaluation and Licensing (PEL)

Issue Date: 3/22/2024 Page 4 of 7 

 Division/Subsidiary: Enter ONLY if the given label lists a subsidiary or division of the establishment. Select from a picklist 

of divisions/subsidiaries recognized on the establishment license.

Distributor: Enter ONLY if the label is a container or a box label. For export labels, the entity responsible for distributing

the vaccine in the country of destination may be variably identified as the distributor, importer, marketer, or equivalent.

Consider all of these roles as distributorsfor this data field. Type any part of the Distributor name to display a list of 

choices in the CVB Distributor list. If the desired Distributor is not displayed, select “Not Listed.” Upon receipt of a “Not 

Listed” submission, the CVB will add the new Distributor to the picklist for future use.

 Comments: Enter any comments specific to the individual label being uploaded.

 Add Row: Click the Add Row button to enter the following information for the label needing replaced. 

 Label Number: If the current label replaces label(s) already on file with the CVB, provide the CVB label # of the label

being replaced (NOT the mail log # under which it was processed). If more than one label is replaced by the current 

label, additional rows may be added.

Use Remaining Inventory: For each label being replaced, check whether permission is being requested to use existing

inventories of the replaced labels. Typically, use of replaced labels is authorized for an additional year, unless other

arrangements are specifically requested and authorized by the CVB. If there is no need to use remaining inventories 

once the replacement label is approved, leave the checkbox blank.
 NCAH PORTAL USER GUIDE #11 v.1

Submitting Labels to Policy, Evaluation and Licensing (PEL)

Issue Date: 3/22/2024 Page 5 of 7 

Appearance in portal once submitted:

Appearance in portal once processed:

• Documents other than the actual labels on mounting sheets may be added with the attachment type “Incoming 

(Core) Document”.

• Such supporting documents may include, but are not limited to, proof of foreign registration, English 

translations of foreign text (if not included on mounting sheet), or any other necessary background information.

• Do NOT attach APHIS Form 2015, as this is not necessary for portal submissions.

Once a label submission is submitted to the CVB, the portal usersees the following:

• The mail log number for the entire submission.

• CVB label numbers for each label attachment.

• Click on Label Info to see specific details entered about each label.

Each new label processed, as well as any labels replaced, will show in the Labels Impacted section. This listing 

reflects CVB’s official actions, which may not correspond exactly to requested actions. The Labels Note: Impacted 

table will reflect real-time status of the labels for as long as the entry can be viewed via portal and not a fixed status 

at the point in time the submission was completed.

Attaching othersupporting documents
 NCAH PORTAL USER GUIDE #11 v.1

Submitting Labels to Policy, Evaluation and Licensing (PEL)

Issue Date: 3/22/2024 Page 6 of 7 

There also will be a file returned for each label submitted. There also may be a comments document; if there are 

no comments, there will be a “No Return Form Comments” statement in the CVB Response section.

Appearance in portal once processed: (continued)